Services
Software is half the job. We help with the other half.
Going digital in a regulated environment means configuration, validation, procedures and people. Our team works alongside your QA and IT to take OneXPro from first meeting to a validated, trusted system.
Implementation & configuration
We set OneXPro up around how your site already works.
- Company, departments, department codes and clients
- Users, designations, groups and administrators
- Your change control flow: who fills each section and signs each box
- Numbering, time zone and principal-party (client) contacts
Computerised system validation support
A risk-based, GAMP 5-aligned path to a validated state.
- Validation plan tailored to your intended use
- Execution support for IQ, OQ and PQ using our versioned protocols
- Traceability from your user requirements to tested functions
- Deviation handling and the validation summary report
GxP spreadsheet remediation
Turn uncontrolled Excel files into controlled, reviewable records.
- Inventory and risk ranking of your GxP spreadsheets
- Building controlled templates with locked values and permission sets
- Defining reviewer, approver and signer roles per template
- Migration of in-use workbooks into Spreadsheet Review
Part 11 & data integrity gap assessment
An honest view of where your current records stand.
- Review of current paper and electronic record practices against 21 CFR Part 11 and EU GMP Annex 11
- ALCOA+ data integrity assessment of the records in scope
- Prioritised remediation plan with the procedural controls you will need
- Input for your SOPs on access, e-signature use and audit-trail review
Paper-to-digital migration
Retire the paper register without losing history.
- Continuing your existing number sequences without gaps or repeats
- Mapping your form's sections and impact items
- Cut-over planning so open paper records close cleanly
- Parallel-run support during go-live
Training
Role-based sessions, with records you can file.
- Initiators, department heads and reviewers
- QA: issuance, impact assessment, classification and approval
- Company administrators: users, flow, departments and clients
- Train-the-trainer for your internal champions
Support
Ongoing support, under change control of its own.
Product updates are versioned and documented so you can assess their impact before you rely on them, and the validation package is updated with every documented change.
Help when you need it
E-mail support for administrators and key users, with issues tracked to resolution.
Release information
What changed, why, and which requirements and tests it touches — for your change control.
Tell us where you are today.
Paper, spreadsheets or a legacy system — we'll propose a practical, validated path forward.